INDICATION
MOTPOLY XR is indicated for adults and pediatric patients weighing at least 50 kg for treatment of partial-onset seizures and adjunctive therapy in the treatment of primary generalized tonic‑clonic seizures.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors.
- MOTPOLY XR may cause dizziness and ataxia in patients. Advise patients not to operate machinery or motor vehicles until they know how MOTPOLY XR affects them.
- Obtain ECG before beginning MOTPOLY XR, and after titration to steady-state maintenance dose in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction. Closely monitor these patients.
- MOTPOLY XR may cause syncope.
- Gradually withdraw MOTPOLY XR to minimize the potential of increased seizure frequency.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multi-organ hypersensitivity has been reported and can be life-threatening or fatal. If signs or symptoms are present, immediately evaluate the patient. Discontinue MOTPOLY XR if there is no alternative etiology.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence.
USE IN SPECIFIC POPULATIONS:
- Dose adjustment is recommended for severe renal impairment and mild or moderate hepatic impairment. Consider dose reduction in patients with renal or hepatic impairment taking strong inhibitors of CYP3A4 and CYP2C9.
- Use is not recommended in severe hepatic impairment.
- Based on animal data, MOTPOLY XR may cause fetal harm if used in pregnancy.
Please refer to the full Prescribing Information and Medication Guide for MOTPOLY XR for additional important information.
References:
1. Data on file, Aucta Pharmaceuticals; 2022.
2. Chung S, Ben-Menachem E, Sperling MR, et al. Examining the clinical utility of lacosamide: pooled analyses of three phase II/III clinical trials. CNS Drugs. 2010;24(12):1041–1054.
3. Wechsler RT, Li G, French J, et al. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014;55(7):1088-1098.
4. Vimpat [package insert]. Smyrna, GA: UCB, Inc.; 2021.
5. Biton V, Gil-Nagel A, Isojarvi J, et al. Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials. Epilepsy Behav. 2015;52:119-127.